MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ENBF3216C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A talent and endurant stent graft system was implanted in a patient for the endovascular treatment of a 70mm diameter abdominal aortic aneurysm.It was reported that ct exam was performed approximately 7 years post the index procedure where it was observed by the physician that either a tear or a separation between the stent graft had occurred.As per the physician, the cause of the event was anatomy related due to angulated aorta, in addition to the time since implantation and the off label nature of this case.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Additional information received reported intervention was attempted to reline the stent graft, but the device would not advance up the external iliac arteries and so the procedure was aborted.The type of type iii endoleak cannot be confirmed.Film evaluation summary: the exact cause of the reported stent graft tear and/or detachment could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not available.Ct¿s returned from ~7 years post-implant revealed that the patient had a thoraco-abdominal aneurysm that had been treated with a talent thoracic and endurant aaa stent graft system.A single talent thoracic device was positioned proximally within the descending thoracic, extending distally across the visceral vessels and renal arteries (which had all been bypassed), and into the proximal portion of the aaa.Near the mid-length of the talent device, where the descending thoracic was acutely angulated ~90 deg, the connecting bar was seen fractured and at least 1 stent fracture was also confirmed near this same location.The endurant bifurcate was positioned within the infrarenal aorta.The suprarenal stents were seen overlapping the distal stent ring of the talent thoracic device; however, the proximal fabric of the endurant did not appear to be sufficiently overlapping the distal talent device.The endurant iliac limbs were angulated at the flow divider ~80 deg to the bifurcate aortic body, and the limbs appeared well sealed distally into the common iliac arteries; bilaterally.The maximum taa diameter near the mid-length of the talent measured 66mm, and near the level of the bifurcate flow divider the aaa max diameter measured ~45mm.Although no clear contrast was seen outside the stent grafts, it is possible that a type iiib endoleak from talent fabric tears and a type iiia junctional endoleak due to stent graft detachment between the talent and endurant bifurcate may have been pressurizing the taa/aaa.The exact cause of the talent connecting bar and stent fractures, and the likely stent graft detachment between the distal thoracic and bifurcate is unknown.This appeared most likely to have been anatomy related due to the angulated thoracic which may have occurred due to disease progression and aneurysm morphology changes.The fractured c-bar and stents also may have led to fabric holes and a resulting type iiib fabric endoleak.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7403416
• Report Number: 2953200-2018-00511
• Device Sequence Number: 785268
• Product Code: MIH
• UDI-Device Identifier: 00613994762429
• UDI-Public: 00613994762429
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2013
• Device Model Number: ENBF3216C166E
• Device Catalogue Number: ENBF3216C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR